Implant inserter

ABSTRACT

A system for implant delivery includes a n implant and an inserter. The implant includes a body that extends between first and second ends. The implant includes retainers extending outwardly from the first and second ends. The retainers are received in corresponding jaws of the inserter. When the implant is connected to the inserter and the inserter is actuated, the implant elastically deforms.

TECHNICAL FIELD

The present disclosure is made in the context of an inserter for acompression bone staple. However, one of skill in the art willappreciate that the disclosed technology is broadly applicable outsidethis context to implants that are movable between a free state and anelastically deformed state.

BACKGROUND

Staples of various designs are used for fixation in surgical procedures.In such procedures, two human body parts, e.g. bones, on either side ofan interface, are joined together by drilling parallel holes in the bodyparts on either side of the interface and inserting the legs of a stapleinto the holes. The legs of the staple are substantially parallel toeach other when they are inserted into the holes, but the staple isconstructed so that after the staple has been implanted, the ends of thelegs converge forcefully towards each other, and thus substantiallyimmobilize the interface. Continuing compression of the body parts hasadditional benefits, for example continuing compression of bones at theinterface promotes bone regrowth. The known surgical staples arecomposed of a shape memory metal (e.g. a nickel titanium alloy) or anelastic polymeric material, for example polyetherether ketone (PEEK).The known procedures for inserting staples into bones are complicatedand expensive.

SUMMARY

The various systems and methods of the present technology have beendeveloped in response to the present state of the art, and inparticular, in response to the problems and needs in the art that havenot yet been fully solved by currently available systems with implantsand inserters.

In an aspect of the technology, a system includes: an implant includinga body, a left retainer, and a right retainer, wherein the body extendsbetween a left end and a right end to establish a longitudinal directionof the body, wherein the left retainer protrudes from the left end ofthe body, wherein the right retainer protrudes from the right end of thebody; and an inserter releasably connectable to the implant, theinserter including a left connection, a right connection, and anintermediate connection between the left and right connections; whereinwhen the inserter is connected to the implant, the left connectionengages the left retainer, the right connection engages the rightretainer, and the intermediate connection is adjacent to the body;wherein when the inserter is connected to the implant, the system ismovable between a free state and an actuated state, wherein in the freestate the body is undeformed by the inserter, wherein in the actuatedstate the body is elastically deformed by pressure from the intermediateconnection acting against resistance from the left and rightconnections.

Various embodiments of this aspect of the technology may include any orall of the following characteristics. The left and right retainersextend along the longitudinal direction of the body. The body extendsbetween a front side and an opposite back side to establish a front toback direction of the body, wherein the left and right retainers extendalong the front to back direction. The body extends between a body lowersurface and an opposite body upper surface, wherein the left retainerextends between a left lower surface and an opposite left upper surface,wherein the right retainer extends between a right lower surface and anopposite right upper surface, wherein the body upper surface and theleft and right lower surfaces are on the same side of the body lowersurface. When the inserter is connected to the implant, the body uppersurface and the entire inserter are on the same side of the body lowersurface. The body lower surface is a bone facing surface. The leftconnection is a left jaw, wherein the right connection is a right jaw,wherein the intermediate connection is a junction; wherein when theinserter is connected to the implant, the left jaw engages under theleft retainer, the right jaw engages under the right retainer, and thejunction is adjacent to the body.

In another aspect of the technology, a system includes: an implantincluding a body, a left retainer, and a right retainer, wherein thebody includes a bone contacting surface, wherein the body extendsbetween a left end and a right end to establish a longitudinal directionof the body, wherein the left retainer protrudes from the left end ofthe body, wherein the right retainer protrudes from the right end of thebody; and an inserter releasably connectable to the implant, theinserter including a left connection, a right connection, and anintermediate connection between the left and right connections; whereinwhen the inserter is connected to the implant, the left connectionengages the left retainer, the right connection engages the rightretainer, and the intermediate connection is adjacent to the body,wherein the left and right retainers and the entire inserter are all onthe same side of the bone contacting surface; wherein when the inserteris connected to the implant, the system is movable between a free stateand an actuated state, wherein in the free state the body is undeformedby the inserter, wherein in the actuated state the body is elasticallydeformed by pressure from the intermediate connection acting againstresistance from the left and right connections.

Various embodiments of this aspect of the technology may include any orall of the following characteristics. The left and right retainersextend along the longitudinal direction of the body. The body extendsbetween a front side and an opposite back side to establish a front toback direction of the body, wherein the left and right retainers extendalong the front to back direction. The body includes an upper surfaceopposite the bone contacting surface, wherein the left retainer extendsbetween a left lower surface and an opposite left upper surface, whereinthe right retainer extends between a right lower surface and an oppositeright upper surface, wherein the upper surface of the body and the leftand right lower surfaces are on the same side of the bone contactingsurface. The left connection is a left hook, wherein the rightconnection is a right hook, wherein the intermediate connection is ajunction; wherein when the inserter is connected to the implant, theleft hook engages under the left retainer, the right hook engages underthe right retainer, and the junction is adjacent to the body.

In yet another aspect of the technology, a system includes: a bonestaple including a bridge, a left leg, a right leg, a left retainer, anda right retainer, wherein the bridge extends between a left end and aright end to establish a longitudinal direction of the bridge, whereinthe left leg includes a left proximal end that is attached to the leftend of the bridge, wherein the left leg terminates in a left distal endopposite the bridge, wherein the right leg includes a right proximal endthat is attached to the right end of the bridge, wherein the right legterminates in a right distal end opposite the bridge, wherein the rightleg extends beside the left leg, wherein the left and right proximalends are separated by a first distance, wherein the left retainer isattached to and extends from the left end of the bridge, wherein theright retainer is attached to and extends from the right end of thebridge, wherein the bone staple is movable between a staple free stateand an elastically deformed state, wherein when the bone staple is inthe staple free state, the staple is undeformed and the left and rightdistal ends are separated by a second distance which is less than thefirst distance, wherein when the bone staple is in the elasticallydeformed state, the left and right distal ends are separated by a thirddistance which is greater than the second distance; and an inserterreleasably connectable to the bone staple, the inserter including a leftconnector, a right connector, and an intermediate connector, wherein theleft connector faces the right connector, wherein the intermediateconnector is between the left and right connectors, wherein the inserteris movable between an inserter free state and an actuated state; whereinwhen the inserter in the inserter free state is connected to the bonestaple in the staple free state, the left connector engages the leftretainer, the right connector engages the right retainer, and theintermediate connector is adjacent to the bridge, between the left andright ends of the bridge, and opposite the left and right legs; whereinwhen the inserter in the actuated state is connected to the bone staplein the elastically deformed state, the left connector engages the leftretainer, the right connector engages the right retainer, and theintermediate connector presses against the bridge between the left andright ends of the bridge and opposite the left and right legs.

Various embodiments of this aspect of the technology may include any orall of the following characteristics. The left and right retainersextend along the longitudinal direction.

The bridge extends between a front side and an opposite back side toestablish a front to back direction of the bridge, wherein the left andright retainers extend along the front to back direction.

The bridge extends between a bridge lower surface and an opposite bridgeupper surface, wherein the left retainer extends between a left lowersurface and an opposite left upper surface, wherein the right retainerextends between a right lower surface and an opposite right uppersurface, wherein the bridge upper surface and the left and right lowersurfaces are on the same side of the bridge lower surface. When theinserter is connected to the bone staple, the bridge upper surface andthe entire inserter are on the same side of the bridge lower surface.The bridge lower surface is a bone contacting surface. The thirddistance is equal to the first distance. The third distance is greaterthan the first distance.

These and other features and advantages of the present technology willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the technology as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the technology will become more fully apparentfrom the following description and appended claims, taken in conjunctionwith the accompanying drawings. Understanding that these drawings depictonly exemplary embodiments and are, therefore, not to be consideredlimiting of the scope of the technology, the exemplary embodiments willbe described with additional specificity and detail through use of theaccompanying drawings in which:

FIG. 1A is a detail perspective view of a distal portion of a systemwith an implant coupled to an inserter; FIG. 1B is a detail side view ofa distal portion of the system of FIG. 1A; and FIG. 1C is a perspectiveview of the system of FIG. 1A;

FIG. 2A is a front view of an implant for use in the system of FIG. 1A;and FIG. 2B is a perspective view of the implant of FIG. 2A;

FIG. 3A is a front view of another implant for use in the system of FIG.1A; and FIG. 3B is a perspective view of the implant of FIG. 2A;

FIG. 4A is an exploded perspective view of the inserter of FIG. 1A; andFIG. 4B is another exploded perspective view of the inserter of FIG. 1Afrom a different direction;

FIG. 5A is a perspective view of another system with yet another implantcoupled to another inserter; and FIG. 5B is a detail front view of adistal portion of the system of FIG. 5A;

FIG. 6A is a detail perspective view of a distal portion of a body ofthe inserter of FIG. 5A; and FIG. 6B is another detail perspective viewof the distal portion of the body of FIG. 6A from a different direction;

FIG. 7 is a perspective view of a control member of the inserter of FIG.5A;

FIG. 8 is a perspective view of left and right capture members of theinserter of FIG. 5A; and

FIG. 9A is a perspective view of the implant of FIG. 5A; FIG. 9B is anexploded perspective view of the implant of FIG. 5A; FIG. 9C is a frontview of the implant of FIG. 5A; and FIG. 9D is a side view of theimplant of FIG. 5A.

DETAILED DESCRIPTION

Exemplary embodiments of the technology will be best understood byreference to the drawings, wherein like parts are designated by likenumerals throughout. It will be readily understood that the componentsof the technology, as generally described and illustrated in the figuresherein, could be arranged and designed in a wide variety of differentconfigurations. Thus, the following more detailed description of theembodiments of the apparatus, system, and method is not intended tolimit the scope of the invention, as claimed, but is merelyrepresentative of exemplary embodiments of the technology.

The phrases “connected to,” “coupled to” and “in communication with”refer to any form of interaction between two or more entities, includingmechanical, electrical, magnetic, electromagnetic, fluid, and thermalinteraction. Two components may be functionally coupled to each othereven though they are not in direct contact with each other. The term“abutting” refers to items that are in direct physical contact with eachother, although the items may not necessarily be attached together. Thephrase “fluid communication” refers to two features that are connectedsuch that a fluid within one feature is able to pass into the otherfeature.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. While the various aspects of theembodiments are presented in drawings, the drawings are not necessarilydrawn to scale unless specifically indicated.

Standard medical planes of reference and descriptive terminology areemployed in this specification. A sagittal plane divides a body intoright and left portions. A mid-sagittal plane divides the body intobilaterally symmetric right and left halves. A coronal plane divides abody into anterior and posterior portions. A transverse plane divides abody into superior and inferior portions. The sagittal, coronal, andtransverse planes are mutually perpendicular. Anterior means toward thefront of the body. Posterior means toward the back of the body. Superiormeans toward the head. Inferior means toward the feet. Medial meanstoward the midline of the body. Lateral means away from the midline ofthe body. Axial means toward a central axis of the body. Abaxial meansaway from a central axis of the body. Ipsilateral means on the same sideof the body. Contralateral means on the opposite side of the body. Thesedescriptive terms may be applied to an animate or inanimate body.

Referring to FIGS. 1A-1C, a system 1100 includes an implant 1200 and aninserter 1300. The system 1100 may be referred to as a delivery deviceand the inserter 1300 may be referred to as a delivery member. Theimplant 1200 is shown coupled to the inserter 1300, with the implant andinserter in their free states. The illustrated implant 1200 is acompression bone staple.

Referring to FIGS. 2A-2B, the implant 1200 includes bone engagingmembers 1202, 1204 which may be integral to an implant bridge 1206, alsoreferred to as an implant body. The bone engaging members 1202, 1204 maybe referred to as legs. The bone engaging member 1202 extends from aleft end 1230 of the implant bridge 1206 and the bone engaging member1204 extends from an opposite right end 1232 of the implant bridge 1206.Bone engaging member 1202 has a proximal end 1234 attached to the leftend 1230 of the implant bridge 1206 and an opposite distal end 1236which is a free end. Bone engaging member 1204 has a proximal end 1238attached to the right end 1232 of the implant bridge 1206 and anopposite distal end 1240 which is a free end. Implant bridge 1206 has anupper surface 1208, a lower surface 1210, a front surface 1209, and anopposite back surface (not shown). The lower surface 1210 may bereferred to as a bone facing surface. Bone engaging member 1202 extendsfrom the lower surface 1210 beside bone engaging member 1204. The boneengaging members 1202, 1204 may have features 1212 that may improve bonepurchase or improve pull out strength of the implant 1200 from bone orsoft tissue. The features 1212 may be referred to as teeth orserrations. The features 1212 are shown on facing sides of the boneengaging members 1202, 1204 but may be on any or all sides of the boneengaging members. The implant 1200 may have projections or otherconnecting means 1214, 1216 for connection with a means of insertion,such as inserter 1300. The connecting means 1214, 1216 may be referredto as tabs, ears, protrusions, retainers, wings, or retaining members.The connecting means 1214, 1216 are shown extending sideways outwardlyfrom the ends 1230, 1232 of the bridge 1206, respectively, along alongitudinal direction established by the bridge. However, in otherexamples, the connecting means may extend outwardly from the ends 1230,1232 of the bridge 1206, respectively, along a front to back direction.These examples may include four connecting means: left front, left back,right front, and right back. The connecting means 1214, 1216 may havelower surfaces 1218, 1220 respectively that may releasably engage with ameans of insertion that may allow the inserter 1300 or other means ofinsertion to be side loading, top loading or pivotably loaded. Forexample, the inserter 1300 may be described as side loading or pivotablyloading. The lower surfaces 1218, 1220 may be referred to as bone facingsurfaces. Referring to FIG. 2A, the lower surfaces 1218, 1220 areproximally spaced apart from, or proximally offset from, from the lowersurface 1210. The dashed extension lines 1210′, 1210″ in FIG. 2A showthe level of the lower surface 1210 versus the lower surfaces 1218,1220.

The means of insertion may maintain a one piece implant in a firstconfiguration thereby allowing a second implant configuration once theimplant is disassembled from the implant. The first configuration may bean elastically deformed state, for example an insertion state. Thesecond configuration may be a free state or an implanted state. Themeans of insertion may utilize features similar to connecting means 1214and 1216 in combination with other surfaces such as top surface 1208.This combination of means of insertion may be used to maintain one ormore features or arms or projections in a particular configuration. Thiscombination of means of insertion may create a bending modality, such asa three point or four point bend, to maintain a specific implantconfiguration or combination of configurations. A combination ofsurfaces and means of insertion, such as connecting means 1214, may beused on the entire implant or portions of an implant to create ormaintain a particular configuration of an implant. For example, a tabsuch as 1214 and top surface, such as 1208 may be used to maintain oneside of an implant or one arm of an implant in a particularconfiguration. When disassembled, that arm may have a configuration thatis different from or the same as the configuration of the rest of theimplant.

Referring to FIGS. 2A-2B, the implant 1200 is shown uncoupled from theinserter 1300. The implant 1200 is in a free state, or relaxed state,which is the shape of the implant 1200 when no external forces areacting upon the implant 1200, other than gravity; the implant 1200experiences no elastic or plastic deflection or deformation. In the freestate, the bone engaging members 1202, 1204 converge as they extend awayfrom the bridge 1206 so that the distal ends 1236, 1240 are closertogether than are the proximal ends 1234, 1238. An angle 1222 is formedbetween the converging bone engaging members 1202, 1204 in the freestate. The angle 1222 opens toward the bridge 1206. The angle 1222 maybe referred to as a free state angle.

Referring to FIGS. 3A-3B, another implant 1250 may be included in thesystem 1100 instead of implant 1200. The implant 1250 may be identicalto the implant embodiment 2200 described in International PatentApplication Serial No. PCT/US2015/039551.

Referring to FIGS. 3A-3B, the implant 1250 includes bone engagingmembers 1252, 1254 which may be integral to an implant bridge 1256, alsoreferred to as an implant body. The bone engaging members 1252, 1254 maybe referred to as legs. The bone engaging member 1252 extends from aleft end 1280 of the implant bridge 1256 and the bone engaging member1254 extends from an opposite right end 1282 of the implant bridge 1256.Bone engaging member 1252 has a proximal end 1284 attached to the leftend 1280 of the implant bridge 1256 and an opposite distal end 1286which is a free end. Bone engaging member 1254 has a proximal end 1288attached to the right end 1282 of the implant bridge 1256 and anopposite distal end 1290 which is a free end. Implant bridge 1256 has anupper surface 1258, a lower surface 1260, a front surface 1259, and aback surface (not shown). The lower surface 1260 may be referred to as abone facing surface. Bone engaging member 1252 extends from the lowersurface 1260 beside bone engaging member 1254. The bone engaging members1252, 1254 may have features 1262 that may improve bone purchase orimprove pull out strength of the implant 1250 from bone or soft tissue.The features 1262 may be referred to as teeth or serrations. Thefeatures 1262 are shown on facing sides of the bone engaging members1252, 1254 but may be on any or all sides of the bone engaging members.The implant 1250 may have projections or other connecting means 1264,1266 for connection with a means of insertion, such as inserter 1300.The connecting means 1264, 1266 may be referred to as tabs, ears,protrusions, retainers, wings, or retaining members. The connectingmeans 1264, 1266 are shown extending sideways outwardly from the ends1280, 1282 of the bridge 1256, respectively, along a longitudinaldirection established by the bridge. However, in other examples, theconnecting means may extend outwardly from the ends 1280, 1282 of thebridge 1256, respectively, along a front to back direction. Theseexamples may include four connecting means: left front, left back, rightfront, and right back. The connecting means 1264, 1266 may have lowersurfaces 1268, 1270 respectively that may releasably engage with a meansof insertion that may allow the inserter 1300 or other means ofinsertion to be side loading, top loading or pivotably loaded. Forexample, the inserter 1300 may be described as side loading or pivotablyloading. The lower surfaces 1268, 1270 may be referred to as bone facingsurfaces. Referring to FIG. 3A, the lower surfaces 1268, 1270 areproximally spaced apart from, or proximally offset from, from the lowersurface 1260. The dashed extension lines 1260′, 1260″ in FIG. 3A showthe level of the lower surface 1260 versus the lower surfaces 1268,1270.

The means of insertion may maintain a one piece implant in a firstconfiguration thereby allowing a second implant configuration once theimplant is disassembled from the implant. The first configuration may bean elastically deformed state, for example an insertion state. Thesecond configuration may be a free state or an implanted state. Themeans of insertion may utilize features similar to connecting means 1264and 1266 in combination with other surfaces such as top surface 1258.This combination of means of insertion may be used to maintain one ormore features or arms or projections in a particular configuration. Thiscombination of means of insertion may create a bending modality, such asa three point or four point bend, to maintain a specific implantconfiguration or combination of configurations. A combination ofsurfaces and means of insertion, such as connecting means 1264, may beused on the entire implant or portions of an implant to create ormaintain a particular configuration of an implant. For example, a tabsuch as 1264 and top surface, such as 1258 may be used to maintain oneside of an implant or one arm of an implant in a particularconfiguration. When disassembled, that arm may have a configuration thatis different from or the same as the configuration of the rest of theimplant.

Referring to FIGS. 3A-3B, the implant 1250 is shown uncoupled from theinserter 1300. The implant 1250 is in a free state, or relaxed state,which is the shape of the implant 1250 when no external forces areacting upon the implant 1250, other than gravity; the implant 1250experiences no elastic or plastic deflection or deformation. In the freestate, the bone engaging members 1252, 1254 converge as they extend awayfrom the bridge 1256 so that the distal ends 1286, 1290 are closertogether than are the proximal ends 1284, 1288. An angle 1272 is formedbetween the converging bone engaging members 1252, 1254 in the freestate. The angle 1272 opens toward the bridge 1256. The angle 1272 maybe referred to as a free state angle.

The implants 1200, 1250 may be fabricated from any suitably elasticbiocompatible material. The implants 1200, 1250 are preferably made ofmetal or polymer, preferably nitinol or polyetheretherketone (PEEK).

Referring to FIGS. 1A-1C and 4A-4B, the inserter 1300 includes a body1400, a first arm 1500, and a second arm 1600. The first and second arms1500, 1600 are separate component parts in this example, however thefirst and second arms 1500, 1600 may optionally be integrally formedwith the body 1400 as a single part.

The illustrated inserter 1300 has a first plane of symmetry along plane1 of FIG. 1A and a second plane of symmetry along plane 2 of FIG. 1B,which is shown edge on and is thus represented by a line 2. The firstand second planes of symmetry are perpendicular to each other. The firstplane of symmetry divides the inserter 1300 into left and right halves.The second plane of symmetry divides the inserter 1300 into front andback halves. The first and second planes of symmetry also apply to theimplant 200 and the body 1400. However, in other examples, the inserter1300 and/or implant 200 may have only one plane of symmetry, or no planeof symmetry so that they are asymmetric.

The body 1400 is an elongated part that extends between a distal end1402 and an opposite proximal end 1404. The distal end 1402 may bereferred to as a working portion and the proximal end 1404 may bereferred to as a handle. The body 1400 has a front surface 1406, anopposite back surface 1408, a left side 1410, and an opposite right side1412. The body 1400 includes a left half 1418 and a right half 1420. Theleft and right halves 1418, 1420 may be mirror images of each other,except for the clip features discussed below. The left half 1418 has adistal portion 1422 and a proximal portion 1424. The right half 1420 hasa distal portion 1426 and a proximal portion 1428.

The left and right halves 1418, 1420 may be joined together by anoptional flex bridge 1432, which biases the proximal portions 1424, 1428away from each other. The flexible bridge 1432 is shown with a bend toenhance flexibility of the flex bridge. The flex bridge 1432 may bereplaced by another type of biasing element, such as a spring. The flexbridge 1432 is shown integral with the body 1400, but the flex bridgemay be a separate component part, for example a metal ribbon coupled tothe left and right halves 1418, 1420.

The distal portions 1422, 1426 may be joined together at a centraljunction 1430. The junction 1430 may be referred to as an intermediateconnection. The body 1400 includes a left arm recess 1414 and a rightarm recess 1416. The left arm recess 1414 extends into the left side1410 at the distal end 1402. The right arm recess 1416 extends into theright side 1412 at the distal end 1402. The right arm recess 1416 is amirror image of the left arm recess 1414 in this example. When the firstand second arms 1500, 1600 are integrally formed with the body 1400, thearm recesses 1414, 1416 are not present.

The proximal portions 1424, 1428 may be enlarged and rounded to formcomfortable handles for a user to grasp. The left proximal portion 1424may optionally include a first clip feature 1434 and the right proximalportion 1428 may optionally include a second clip feature 1436. Thefirst and second clip features 1434, 1436 cooperate to releasably holdthe left proximal portion 1424 at a fixed distance from the rightproximal portion 1428. The first clip feature 1434 includes a recess1438 that receives and releasably retains a tooth 1440 included in thesecond clip feature 1436. Multiple recesses and/or teeth may be includedto provide multiple different fixed distances between the proximalportions 1424, 1428. The engagement between the recess 1438 and thetooth 1440 may be released by actuating a lever 1442 or other controlfeature. The lever 1442 is shown included in the second clip feature1436 but can instead be included in the first clip feature 1436. Thefirst and second clip features 1434, 1436 may be integral with the body1400 as shown, or optionally may be separate component parts coupled tothe left and right halves 1418, 1420. The clip features 1434, 1436 shownmay be replaced with a ratchet mechanism or other releasable retentionmechanism.

The first arm 1500 is an elongated part that extends between a distalend 1502 and an opposite proximal end 1504. The first arm 1500 has afront surface 1506, an opposite back surface 1508, an outer side 1510,and an opposite inner side 1512. The distal end 1502 may be referred toas a jaw or a connection. The distal end 1502 terminates in a small hook1520 that protrudes from the inner side 1512. The hook 1520 may bereferred to as a formation, a clip (distinct from the first and secondclip features 1434, 1436), a connection, or a capture member.

The second arm 1600 in this example is identical to the first arm 1500.However, to differentiate the two parts, the second arm is givenreference number series 1600.

The second arm 1600 is an elongated part that extends between a distalend 1602 and an opposite proximal end 1604. The second arm 1600 has afront surface 1606, an opposite back surface 1608, an outer side 1610,and an opposite inner side 1612. The distal end 1602 may be referred toas a jaw or a connection. The distal end 1602 terminates in a small hook1620 that protrudes from the inner side 1612. The hook 1620 may bereferred to as a formation, a clip (distinct from the first and secondclip features 1434, 1436), a connection, or a capture member.

The body 1400 may be fabricated from any suitable material. The body1400 is preferably made of metal or polymer, preferably stainless steelor polycarbonate. The first and second arms 1500, 1600 may be fabricatedfrom any suitable material. The first and second arms 1500, 1600 arepreferably made of metal or polymer, preferably stainless steel orpolycarbonate. In one example, the body 1400 is made of a polymer andthe first and second arms 1500, 1600 are made of hardened steel. Inanother example, the body 1400 and the arms 1500, 1600 are integrallyformed as a single part made of metal, preferably an elastic metal suchas spring steel. In yet another example, the body 1400 and the arms1500, 1600 are integrally formed as a single part made of polymer.

The first arm 1500 is coupled to the body 1400 so that the distal end1402 and the distal end 1502 face the same direction, the front surface1406 and the front surface 1506 face the same direction, the backsurface 1408 and the back surface 1508 face the same direction, and theinner side 1512 faces into the left arm recess 1414. The second arm 1600is coupled to the body 1400 so that the distal end 1402 and the distalend 1602 face the same direction, the front surface 1406 and the backsurface 1608 face the same direction, the back surface 1408 and thefront surface 1606 face the same direction, and the inner side 1612faces into the right arm recess 1416. When the first and second arms1500, 1600 are coupled to the body 1400, the concave sides of the hooks1520, 1620 face each other. The first and second arms 1500, 1600 may becoupled to the body 1400 by screws, pins, rivets, press fit, dovetailconnection, adhesive, over molding, insert molding, or other means.Preferably, the first and second arms 1500, 1600 are rigidly coupled tothe body 1400, and are removable for cleaning or replacement. Asmentioned previously, the first and second arms 1500, 1600 mayoptionally be integrally formed with the body 1400 as a single part.

When the inserter 1300 is fully assembled as shown in FIG. 1C, as theproximal portions 1424, 1428 are moved toward each other, the left andright halves 1418, 1420 pivot about the central junction 1430 so thatthe hooks 1520, 1620 rotate proximally relative to the central junction1430, the optional flex bridge 1432 deforms so that the proximal bendbecomes more pronounced, and, if present, the first and second clipfeatures 1434, 1436 move towards each other so that eventually the tooth1440 is received in the recess 1438. The flex bridge preferably deformselastically. When the proximal portions 1424, 1428 are pressed inwardlytoward each other against the resistance of the flex bridge 1432, theinserter 1300 is in a compressed state, also referred to as an actuatedstate. When the tooth 1440 is received in the recess 1438, the inserter1300 is in a locked state. If there are multiple recesses 1438 and/orteeth 1440, then when the first tooth/recess are engaged, the inserter1300 is in a first locked state; when the second tooth/recess areengaged, the inserter 1300 is in a second locked state; and so on forthird, fourth, or higher locked states. If present, the first and secondclip features 1434, 1436 may be disengaged or released by pressing thelever 1442 toward the right proximal portion 1428. As the proximalportions 1424, 1428 are moved away from each other, the left and righthalves 1418, 1420 pivot about the central junction 1430 so that thehooks 1520, 1620 rotate distally relative to the central junction 1430,the flex bridge 1432 relaxes so that the proximal bend becomes lesspronounced, and, if present, the first and second clip features 1434,1436 move away from each other. The proximal portions 1424, 1428 may bebiased by the flex bridge 1432 to move away from each otherautomatically as soon as inward pressure on the proximal portions 1424,1428 is released, or, if present, as soon as the first and second clipfeatures 1434, 1436 are disengaged or released. When the first andsecond clip features 1434, 1436 are disengaged or released, the inserter1300 is in an unlocked state. When the flex bridge 1432 has relaxed toits free state, the inserter 1300 is in a free state.

Referring to FIG. 1A-1C, the implant 1200 is shown coupled or connectedto the inserter 1300. The implant 1200 and inserter 1300 are each in thefree state. The implant 1200 is coupled to the inserter 1300 by engagingthe hooks 1520, 1620 of the first and second arms 1500, 1600 under theconnecting means 1214, 1216 of the implant 1200, for example by slidingor twisting. The inserter 1300 is secured to, for example, clips over,around, and/or underneath the retaining members of the implant 1200.With the bridge 1206 parallel to the second plane of symmetry as shownin FIGS. 1A-1C, the connecting means 1214, 1216 and the bridge 1206 mayslide straight into engagement with the hooks 1520, 1620 from the frontor back of the inserter 1300. Alternately, the hooks 1520, 1620 mayslide under the connecting means 1214, 1216 along the longitudinaldirection established by the bridge. Alternately, with the bridgeparallel to the first plane of symmetry, the middle of the bridge 1206may be placed adjacent to the central junction 1430 and the implant 1200may be twisted clockwise or counterclockwise relative to the inserter1300 to rotate the connecting means 1214, 1216 into engagement with thehooks 1520, 1620. When the implant 1200 is coupled to the inserter 1300,the distal portions 1422, 1426 of the body 1400 extend along and abovethe bridge 1206 of the implant 1200 so that the central junction 1430 isadjacent to a middle portion of the bridge 1206. When the implant 1200and inserter 1300 are each in the free state, the central junction 1430is separated from the bridge 1206 by a gap 1431 (FIG. 1A). The proximalportions 1424, 1428 extend away from the bridge 1206 generally oppositethe bone engaging members 1202, 1204. The implant 1200 may be pre-loadedon the inserter 1300 in a package, such as a sterile package, with theimplant 1200 in the free state. The implant 1200 is also decoupled ordisconnected from the inserter 1300 by disengaging the hooks 1520, 1620of the first and second arms 1500, 1600 from under the connecting means1214, 1216 of the implant 1200 by sliding or twisting. The connectionbetween the inserter 1300 and the implant 1200 may be ruptured bychanging the shape of the inserter 1300 and/or by twisting the inserter1300 relative to the retaining members. The retaining members remain inplace with the implant 1200 after the inserter 1300 has been removed.

Referring to FIGS. 1A, 1C, and 2A, when the implant 1200 is coupled tothe inserter 1300, the hooks 1520, 1620 may not extend below the lowersurface 1210 of the bridge 1206, due at least in part to the arrangementof the lower surfaces 1218, 1220 of the connecting means 1214, 1216being proximally offset from the lower surface 1210 of the bridge 1206.Instead, the hooks 1520, 1620 may be even with, or flush with, the lowersurface 1210; or proximally spaced apart from, or proximally offsetfrom, the lower surface 1210. More specifically, the distal-most aspectof each hook 1520, 1620 may be at the same level as, or proximal to, thelower surface 1210. This is significant because the lower surface 1210may contact a bone surface when the implant 1200 is implanted. Inexamples where the hooks 1520, 1620 are flush with, or proximally offsetfrom, the lower surface, the implant 1200 may be fully seated againstthe bone surface without interference from the hooks 1520, 1620 againstthe bone surface. Referring to FIG. 2A, the dashed extension lines1210′, 1210″ show the level of the lower surface 1210 when the implant1200 is in the free state. FIGS. 1A, 1C, and 2A also illustrate that thebridge 1206, connecting means 1214, 1216, and the entire inserter 1300are located on the proximal side of the lower surface 1210.

Referring to FIGS. 1A-1C, when the implant 1200 is coupled to theinserter 1300, the inserter 1300 may be actuated to urge the implant1200 into an elastically deformed state. The inserter 1300 may be movedfrom the free state to the compressed state, or the locked state if thefirst and second clip features 1434, 1436 are present (or to a first,second, or higher locked state if multiple locked states are enabled bythe design of the inserter 1300). As the inserter 1300 moves from thefree state to the compressed state or the locked state, the hooks 1520,1620 rotate proximally relative to the central junction 1430 and the gap1431 (FIG. 1A) decreases until the central junction 1430 contacts theupper surface 1208 of the bridge 1206 and presses the bridge distallyagainst the resistance of the hooks 1520, 1620 under the connectingmeans 1214, 1216. In the example, the central junction 1430 contacts andpushes against the middle of the upper surface 1208 to put the bridgeinto three point bending. However, the central junction 1430 may bedesigned to contact and push against a different location along theupper surface 1208, or multiple locations. A central junction designedto contact two separate locations along the upper surface 1208 would putthe bridge into four point bending, for example. While in theillustrated example, the proximal portions 1424, 1428 are moved towardeach other to actuate the inserter 1300, in other examples the proximalportions 1424, 1428 may be moved away from each other, or otherwisemoved relative to each other, to actuate the inserter 1300.

Actuating the inserter 1300 from the free state to the compressed stateor the locked state puts the implant 1200 into an elastically deformedstate in which the distal ends 1236, 1240 of the bone engaging members1202, 1204 are farther away from each other than they are in the implantfree state. The inserter 1300 may urge the implant 1200 into a firstelastically deformed state in which the distal ends 1236, 1240 arefarther apart than they are in the implant free state, but not as farapart as the proximal ends 1234, 1238, so that the bone engaging members1202, 1204 still converge slightly; a second elastically deformed statein which the distal ends 1236, 1240 and the proximal ends 1234, 1238 arethe same distance apart, so that the bone engaging members 1202, 1204are parallel, at least to the unaided eye; or a third elasticallydeformed state in which the distal ends 1236, 1240 are farther apartthan are the proximal ends 1234, 1238, so that the bone engaging members1202, 1204 diverge.

As the inserter 1300 moves from the compressed state or the locked stateto the free state, the hooks 1520, 1620 rotate distally relative to thecentral junction 1430 and the central junction 1430 moves away from theupper surface 1208 of the bridge 1206 to allow the bridge 1206 and theentire implant 1200 to relax toward the implant free state.

The implant 1200 may be decoupled or disconnected from the inserter 1300when the implant 1200 is in the free state or an elastically deformedstate. The inserter 1300 may be decoupled or disconnected from theimplant 1200 when the inserter 1300 is in the free state, the unlockedstate, the compressed state, or a locked state if the first and secondclip features 1434, 1436 are present.

A surgical method for stabilizing first and second bone fragments mayinclude any or all of the following steps in any order: preparing afirst hole in the first bone fragment; inserting a temporary fixationpin in the first hole; preparing a second hole in the second bonefragment; determining an implant size corresponding to the first andsecond holes; selecting the proper size implant 1200; coupling theselected implant 1200 to the inserter 1300, the implant 1200 in the freestate; urging the implant 1200 into an elastically deformed state;inserting the bone engaging member 1202 into the first hole and the boneengaging member 1204 into the second hole; seating the lower surface1210 against a surface of the first or second bone fragment; allowingthe implant 1200 to relax toward the implant free state; and decouplingthe inserter 1300 from the implant 1200. Allowing the implant 1200 torelax toward the implant free state may comprise releasing inwardpressure on the proximal portions 1424, 1428. Optionally, allowing theimplant 1200 to relax toward the implant free state may comprisedisengaging the first and second clip features 1434, 1436.

Referring to FIGS. 5A-9D, another system 2100 includes an implant 2200and an inserter 2300. The system 2100 may be referred to as a deliverydevice and the inserter 2300 may be referred to as a delivery member. InFIGS. 5A-5B, the implant 2200 is shown coupled to the inserter 2300,with the implant 2200 and inserter 2300 in their free states. Theillustrated implant 2200 is a compression bone staple.

Referring to FIGS. 5A-5B and 9A-9D, the implant 2200 includes boneengaging members 2202, 2204 which may be integral to an implant bridge2206, also referred to as an implant body. The bone engaging members2202, 2204 may be referred to as legs. The bone engaging member 2202extends from a left end 2230 of the implant bridge 2206 and the boneengaging member 2204 extends from an opposite right end 2232 of theimplant bridge 2206. Bone engaging member 2202 has a proximal end 2234attached to the left end 2230 of the implant bridge 2206 and an oppositedistal end 2236 which is a free end. Bone engaging member 2204 has aproximal end 2238 attached to the right end 2232 of the implant bridge2206 and an opposite distal end 2240 which is a free end. Implant bridge2206 has an upper surface 2208, a lower surface 2210, a front surface2209, and a back surface 2211. The lower surface 2210 may be referred toas a bone facing surface. Bone engaging member 2202 extends from thelower surface 2210 beside bone engaging member 2204. The bone engagingmembers 2202, 2204 may have features 2212 that may improve bone purchaseor improve pull out strength of the implant 2200 from bone or softtissue. The features 2212 may be referred to as teeth or serrations. Thefeatures 2212 are shown on facing sides of the bone engaging members2202, 2204 but may be on any or all sides of the bone engaging members.

The implant 2200 may have projections or other connecting means 2214,2216 for connection with a means of insertion, such as inserter 2300.The connecting means 2214, 2216 may be referred to as tabs, ears,protrusions, retainers, wings, or retaining members. The connectingmeans 2214, 2216 are shown extending outwardly from the front surface2209 from the ends 2230, 2232 of the bridge 2206, respectively, along afront to back direction established between the front surface 2209 andthe back surface 2211. This example also includes connecting means 2215,2217 which are identical to connecting means 2214, 2216, respectively,but which extend outwardly from the back surface 2211 from the ends2230, 2232 of the bridge 2206, respectively, along the front to backdirection. Connecting means 2215 is not visible. The connecting means2214, 2215, 2216, 2217 have surfaces 2218, 2219, 2220, 2221respectively. Surface 2219 is not visible. The surfaces 2218, 2219,2220, 2221 may releasably engage with a means of insertion that mayallow the inserter 2300 or other means of insertion to be side loading,top loading, pivotably loaded, or end loading. For example, the inserter2300 may be described as end loading. The surfaces 2218, 2219, 2220,2221 may be referred to as bone facing surfaces since they angleoutwardly and face distally. Referring to FIGS. 5B and 9D, the surfaces2218, 2219, 2220, 2221 are proximally spaced apart from, or proximallyoffset from, from the surface 2210. The dashed extension lines 2210′,2210″ in FIGS. 9C-9D show the level of the surface 2210 versus thesurfaces 2218, 2220, 2221. In this example, connecting means 2214 andsurface 2218 extend across the bridge 2206 toward the right end 2232 tomerge with connecting means 2216 and surface 2220. Likewise, connectingmeans 2217 and surface 2221 extend across the bridge 2206 toward theleft end 2230 to merge with connecting means 2215 and surface 2219.Taken together, the connecting means 2214, 2215, 2216, 2217 and surfaces2218, 2219, 2220, 2221 form a dovetail rail 2213 that extends completelyacross the bridge 2206 from left to right. However, in other examples,the connecting means 2214, 2215, 2216, 2217 may be discrete features.

Referring to FIGS. 9A-9B, the implant 2200 includes an optionalreinforcing member 2250 which may be metal, for example a nickeltitanium alloy. When the implant 2200 includes the reinforcing member,the implant may also include a base member 2252, which in this exampleis the polymer portion of the implant 2200 other than the reinforcingmember 2250. The polymer may be PEEK. The base member 2252 may be easilymolded with the desired three-dimensional characteristics for theimplant 2200. The base member 2252 may include an optional channel 2254into which the optional reinforcing member 2250 is fitted. The implant2200 may be referred to as a hybrid implant 2200 because it includes apolymer base member 2252 and a metal reinforcing member 2250.Alternatively, the implant 2200 may lack the reinforcing member 2250 andthe channel 2254.

The means of insertion may maintain a one piece implant in a firstconfiguration thereby allowing a second implant configuration once theimplant is disassembled from the implant. The first configuration may bean elastically deformed state, for example an insertion state. Thesecond configuration may be a free state or an implanted state. Themeans of insertion may utilize features similar to connecting means 2214and 2216 in combination with other surfaces such as top surface 2208.This combination of means of insertion may be used to maintain one ormore features or arms or projections in a particular configuration. Thiscombination of means of insertion may create a bending modality, such asa three point or four point bend, to maintain a specific implantconfiguration or combination of configurations. A combination ofsurfaces and means of insertion, such as connecting means 2214, may beused on the entire implant or portions of an implant to create ormaintain a particular configuration of an implant. For example, aprotrusion such as 2214 and top surface, such as 2208 may be used tomaintain one side of an implant or one arm of an implant in a particularconfiguration. When disassembled, that arm may have a configuration thatis different from or the same as the configuration of the rest of theimplant.

Referring to FIGS. 9A-9D, the implant 2200 is shown uncoupled from theinserter 2300. The implant 2200 is in a free state, or relaxed state,which is the shape of the implant 2200 when no external forces areacting upon the implant 2200, other than gravity; the implant 2200experiences no elastic or plastic deflection or deformation. In the freestate, the bone engaging members 2202, 2204 converge as they extend awayfrom the bridge 2206 so that the distal ends 2236, 2240 are closertogether than the proximal ends 2234, 2238. An angle 2222 is formedbetween the converging bone engaging members 2202, 2204 in the freestate. The angle 2222 opens toward the bridge 2206. The angle 2222 maybe referred to as a free state angle.

The implant 2200 may be fabricated from any suitably elasticbiocompatible material. The implant 2200 is preferably made of metal orpolymer, preferably nitinol or polyetheretherketone (PEEK).

Referring to FIGS. 5A-8, the inserter 2300 includes a body 2400, a leftcapture member 2500, a right capture member 2600, and a control member2700. The capture members 2500, 2600 are separate component parts inthis example, however the capture members 2500, 2600 may optionally beintegrally formed with the body 2400 as a single part.

The illustrated inserter 2300 has a first plane of symmetry along plane11 of FIG. 5A, which is shown edge on in FIG. 5B and is thus representedby a line 11. The inserter 2300 may have a second plane of symmetryalong plane 12, which is shown edge on in FIG. 9D and is thusrepresented by a line 12. The first and second planes of symmetry areperpendicular to each other. The first plane of symmetry divides theinserter 2300 into left and right halves. The second plane of symmetrydivides the inserter 2300 into front and back halves. The first andsecond planes of symmetry also apply to the implant 200, the optionalreinforcing member 2250, the base member 2252, the body 2400, and thecontrol member 2700. However, in other examples, the inserter 2300and/or implant 200 may have only one plane of symmetry, or no plane ofsymmetry so that they are asymmetric.

Referring to FIGS. 5A-6B, the body 2400 is an elongated part thatextends between a distal end 2402 and an opposite proximal end 2404. Thedistal end 2402 may be referred to as a working portion and the proximalend 2404 may be referred to as a handle. The body 2400 has a frontsurface 2406, an opposite back surface 2408, a left side 2410, and anopposite right side 2412. The body 2400 includes a left half 2418 and aright half 2420. The left and right halves 2418, 2420 may be mirrorimages of each other, except for the clip features discussed below. Theleft half 2418 has a distal portion 2422 and a proximal portion 2424.The right half 2420 has a distal portion 2426 and a proximal portion2428.

Referring to FIGS. 6A-6B, the left and right halves 2418, 2420 may bejoined together by an optional flex bridge 2432, which may bias theproximal portions 2424, 2428 away from each other. The flexible bridge2432 is shown with a bend which may enhance flexibility of the flexbridge. The flex bridge 2432 may be replaced by another type of biasingelement, such as a spring. The flex bridge 2432 is shown integral withthe body 2400, but the flex bridge may be a separate component part, forexample a metal ribbon coupled to the left and right halves 2418, 2420.Alternatively, the bridge 2432 may have the same flexibility as anyother part of the body. The flex bridge 2432 includes a control slot2458 which may have one or more narrow portions 2460 at intermediatelocations along the control slot. One intermediate narrow portion 2460is shown in this example.

The distal portions 2422, 2426 may meet at a central junction 2430. Thejunction 2430 may be referred to as an intermediate connection. In thisexample, the distal portions 2422, 2426 overlap at the central junction2430. The left distal portion 2422 includes a left control pocket 2462in the shape of a proximally concave hook at the central junction 2430.The control pocket 2462 may include one or more narrow portions 2463 atlocations along the control pocket. One proximal narrow portion 2463 isshown in this example. The right distal portion 2426 includes a rightcontrol pocket 2464 in the shape of a proximally concave hook at thecentral junction 2430. The control pocket 2464 may include one or morenarrow portions 2465 at locations along the control pocket. One proximalnarrow portion 2465 is shown in this example. The right control pocket2464 overlaps in front of the left control pocket 2462. This arrangementmay be reversed, and may be further modified to include three or moreinterdigitated control pockets.

The body 2400 includes a left recess 2414 and a right recess 2416. Theleft recess 2414 extends into the distal end 2402 in the left half 2418.The left recess 2414 includes a proximal wide portion 2450 and a distalnarrow portion 2452. The right recess 2416 extends into the distal end2402 in the right half 2420. The right recess 2416 includes a proximalwide portion 2454 and a distal narrow portion 2456. The left recess 2414is identical to the right recess 2416 in this example. The recesses2414, 2416 may be referred to as formations or pockets. The recesses2414, 2416 are optional, and are present when the capture members 2500,2600 are separate from the body 2400. When the capture members 2500,2600 are integrally formed with the body 2400, the recesses 2414, 2416are not present.

Referring to FIG. 5A, the proximal portions 2424, 2428 may be enlargedand rounded, or otherwise adapted to form comfortable handles for a userto grasp. The left proximal portion 2424 may optionally include a firstclip feature 2434 and the right proximal portion 2428 may optionallyinclude a second clip feature 2436. The first and second clip features2434, 2436 cooperate to releasably hold the left proximal portion 2424at a fixed distance from the right proximal portion 2428. The first clipfeature 2434 includes a groove 2438 that receives and releasably retainsa tooth 2440 included in the second clip feature 2436. Multiple groovesand teeth are included to provide a ratchet interconnection thatprovides multiple different fixed distances between the proximalportions 2424, 2428. The first and second clip features 2434, 2436 maybe integral with the body 2400 as shown, or optionally may be separatecomponent parts coupled to the proximal portions 2424, 2428. The clipfeatures 2434, 2436 shown may be replaced with another releasableretention mechanism.

Referring to FIG. 8, the left capture member 2500 has a distal end 2502,an opposite proximal end 2504, a front surface 2506, an opposite backsurface 2508, a left side 2510, and an opposite right side 2512. Thedistal end 2502 may be referred to as a jaw or a connection. The distalend 2502 includes front and back walls 2522, 2524 which define adovetail groove 2526 between the walls. Taken together, the walls 2522,2524 and dovetail groove 2526 may be referred to as a formation, a clip(distinct from the first and second clip features 2434, 2436), aconnection, or a capture member. The proximal end 2504 includes alocking member 2528 which in this example, when viewed from the front orback, is a proximally pointing triangular feature. A securing member2530 extends between the locking member 2528 and the distal end 2502.The securing member 2530 is narrower left to right than the lockingmember 2528, so that bilateral undercuts are formed at the transitionbetween the locking member and the securing member.

The right capture member 2600 in this example is identical to the leftcapture member 2500. However, to differentiate the two parts, the rightcapture member is given reference number series 2600.

The right capture member 2600 has a distal end 2602, an oppositeproximal end 2604, a front surface 2606, an opposite back surface 2608,a left side 2610, and an opposite right side 2612. The distal end 2602may be referred to as a jaw or a connection. The distal end 2602includes front and back walls 2622, 2624 which define a dovetail groove2626 between the walls. Taken together, the walls 2622, 2624 anddovetail groove 2626 may be referred to as a formation, a clip (distinctfrom the first and second clip features 2434, 2436), a connection, or acapture member. At the left side 2610, the walls 2622, 2624 includefront and back tabs 2632, 2634, respectively, which protrude toward eachother, thus narrowing the dovetail groove 2626 at the left side. Thetabs are also present on the left capture member 2500 but are notvisible in FIG. 8; the front tab 2532 is visible in FIG. 5A. Theproximal end 2604 includes a locking member 2628 which in this example,when viewed from the front or back, is a proximally pointing triangularfeature. A securing member 2630 extends between the locking member 2628and the distal end 2602. The securing member 2630 is narrower left toright than the locking member 2628, so that bilateral undercuts areformed at the transition between the locking member and the securingmember.

Referring to FIG. 7, the control member 2700 has a distal end 2702, aproximal end 2704, a front surface 2606, and a back surface 2708. Afront longitudinal element 2714 extends between the distal end 2702 andthe proximal end 2704. A back longitudinal element 2716 extends betweenthe distal end 2702 and the proximal end 2704 and is held spaced apartfrom the front longitudinal element 2714 by a distal stem 2718 and aproximal stem 2720. The stems 2718, 2720 extend in a front to backdirection.

The body 2400, capture members 2500, 2600, and control member 2700 maybe fabricated from any suitable material. The body 2400 is preferablymade of metal or polymer, preferably stainless steel or polycarbonate.The capture members 2500, 2600 are preferably made of metal or polymer,preferably stainless steel or polycarbonate. The control member 2700 ispreferably made of metal or polymer, preferably stainless steel orpolycarbonate. In one example, the body 2400 and control member 2700 aremade of a polymer and the capture members 2500, 2600 are made ofhardened steel. In another example, the body 2400 and the arms 2500,2600 are integrally formed as a single part made of metal, preferably anelastic metal such as spring steel. In yet another example, the body2400 and the arms 2500, 2600 are integrally formed as a single part madeof polymer.

Referring to FIG. 5A, when the inserter 2300 is operatively assembled,the left capture member 2500 is coupled to the body 2400 so that thedistal ends 2402, 2502 face the same direction, the front surfaces 2406,2506 face the same direction, and the left sides 2410, 2510 face thesame direction. The wide portion 2450 of the left recess 2414 receivesthe locking member 2528 and the narrow portion 2452 receives at least aportion of the securing member 2530. The right capture member 2600 iscoupled to the body 2400 so that the distal ends 2402, 2602 face thesame direction, the front surface 2406 and the back surface 2608 facethe same direction, and the right side 2412 and the left side 2610 facethe same direction. The wide portion 2454 of the right recess 2416receives the locking member 2628 and the narrow portion 2456 receives atleast a portion of the securing member 2630 The recesses 2414, 2416engage the bilateral undercuts so that tension may be applied to thecapture members 2500, 2600 by the inserter 2300. The recesses 2414, 2416may receive the securing members 2530, 2630 and locking members 2528,2628 with a close fit or an interference fit, and may even be formedaround the securing members 2530, 2630 and locking members 2528, 2628(or vice versa) in a molding operation. When the capture members 2500,2600 are coupled to the body 2400, the dovetail grooves 2526, 2626 arealigned with each other. The capture members 2500, 2600 may be coupledto the body 2400 by screws, pins, rivets, press fit, dovetailconnection, adhesive, over molding, insert molding, or other means.Preferably, the capture members 2500, 2600 are rigidly coupled to thebody 2400, and are removable for cleaning or replacement. As mentionedpreviously, the capture members 2500, 2600 may optionally be integrallyformed with the body 2400 as a single part. The control member 2700 iscoupled to the body 2400 by inserting the proximal stem 2720 in thecontrol slot 2458, preferably proximally past the narrow portion(s)2460, so that the front longitudinal element 2714 is adjacent to thefront surface 2406 and the back longitudinal element 2716 is adjacent tothe back surface 2408. Alternatively, the back longitudinal element 2716may be adjacent to the front surface 2406 and the front longitudinalelement 2714 may be adjacent to the back surface 2408. The distal stem2718 may then be inserted into the control pockets 2462, 2464 by movingthe control member 2700 distally, preferably so that the distal stem2718 moves past the narrow portions 2463, 2465, preferably until thedistal stem 2718 is fully distally seated in the control pockets 2462,2464. When the distal stem 2718 is in the control pockets 2462, 2464,the proximal stem 2720 may be distally positioned in the control slot2458 distal to at least a proximal one of the narrow portion(s) 2460, ordistally spaced outside the control slot 2458.

When the inserter 2300 is fully assembled as shown in FIG. 5A, with thedistal stem 2718 in the control pockets 2462, 2464, as the proximalportions 2424, 2428 are moved toward each other, the gap 2444 becomessmaller, the left and right halves 2418, 2420 pivot about the centraljunction 2430 so that the capture members 2500, 2600 rotate proximallyrelative to the central junction 2430, the optional flex bridge 2432 maydeform so that the proximal bend becomes more pronounced, and, ifpresent, the first and second clip features 2434, 2436 move towards eachother so that eventually the tooth 2440 is received in the groove 2438.The flex bridge preferably deforms elastically. When the proximalportions 2424, 2428 are pressed inwardly toward each other against theresistance of the flex bridge 2432, the inserter 2300 is in a compressedstate, also referred to as an actuated state. When the tooth 2440 isreceived in the groove 2438, the inserter 2300 is in a locked state.Since there are multiple grooves 2438 and teeth 2440 in this example,then when the first tooth/recess are engaged, the inserter 2300 is in afirst locked state; when the second tooth/recess are engaged, theinserter 2300 is in a second locked state; and so on for third, fourth,or higher locked states. When the distal stem 2718 is in the controlpockets 2462, 2464, the control member 2700 is in a first controlposition. When the inserter 2300 is connected to the implant 2200 andthe control member 2700 is in the first control position, the inserter2300 is captive to the implant 2200; the inserter 2300 cannot bedisconnected from the implant 2200. When the inserter 2300 is notconnected to the implant 2200 and the control member 2700 is in thefirst control position, the inserter cannot be connected to the implant2200.

If present, the first and second clip features 2434, 2436 may bedisengaged or released by the user after the implant 2200 is implanted.With the control member 2700 in the first control position, as theproximal portions 2424, 2428 are moved away from each other, the leftand right halves 2418, 2420 pivot about the central junction 2430 sothat the capture members 2500, 2600 rotate distally relative to thecentral junction 2430, the flex bridge 2432 relaxes so that the proximalbend becomes less pronounced, and, if present, the first and second clipfeatures 2434, 2436 move away from each other. The proximal portions2424, 2428 may be biased by the flex bridge 2432 to move away from eachother automatically as soon as inward pressure on the proximal portions2424, 2428 is released, or, if present, as soon as the first and secondclip features 2434, 2436 are disengaged or released. When the first andsecond clip features 2434, 2436 are disengaged or released, the inserter2300 is in an unlocked state. When the flex bridge 2432 has relaxed toits free state, the inserter 2300 is in a free state. In the free state,the proximal portions 2424, 2428 are separated by a gap 2444 having afree state dimension 2446.

With the inserter 2300 in the free state, the control member 2700 may bemoved proximally to move the proximal stem 2720 into the control slot2458, preferably past at least a distal one of the narrow portion(s)2460, preferably until the proximal stem 2720 is fully proximally seatedin the control slot 2458; and to move the distal stem 2718 out of thecontrol pockets 2462, 2464, preferably proximally past the narrowportions 2463, 2465. When the distal stem 2718 is out of the controlpockets 2462, 2464, the control member 2700 is in a second controlposition in which the inserter 2300 is connectable to, anddisconnectable from, the implant 2200. The inserter 2300 may now beactuated to connect or disconnect the inserter 2300 and the implant2200.

As the proximal portions 2424, 2428 are moved toward each other, the gap2444 becomes smaller, the left and right halves 2418, 2420 pivot aboutthe proximal stem 2720 so that the capture members 2500, 2600 rotateoutwardly left and right, respectively, relative to the proximal stem2720, and, if present, the first and second clip features 2434, 2436move towards each other so that eventually the tooth 2440 is received inthe groove 2438.

As the proximal portions 2424, 2428 are moved away from other, the gap2444 becomes larger, the left and right halves 2418, 2420 pivot aboutthe proximal stem 2720 so that the capture members 2500, 2600 rotateinwardly from left and right, respectively, relative to the proximalstem 2720, and, if present, the first and second clip features 2434,2436 move away from each other.

Referring to FIGS. 5A-5B, the implant 2200 is shown coupled or connectedto the inserter 2300. The implant 2200 and inserter 2300 are each in thefree state. With the control member 2700 in the second control position,the implant 2200 may be coupled to the inserter 2300 by actuating theinserter 2300, engaging the dovetail grooves 2526, 2626 of the capturemembers 2500, 2600 to the connecting means 2214, 2215, 2216, 2217 of theimplant 2200, for example by sliding, and spreading apart the proximalportions 2424, 2428 of the inserter 2300. The inserter 2300 is securedto, for example, clips over, around, and/or underneath the connectingmeans of the implant 2200. With the bridge 2206 parallel to the secondplane of symmetry as shown in FIGS. 5A-5B, the dovetail grooves 2526,2626 may slide straight into engagement with the connecting means 2214,2215, 2216, 2217 along the longitudinal direction established by thebridge 2206. In the example shown, the dovetail grooves 2526, 2626 slideonto the dovetail rail 2213. When the implant 2200 is coupled to theinserter 2300, the distal portions 2422, 2426 of the body 2400 extendalong and above the bridge 2206 of the implant 2200 so that the centraljunction 2430 is adjacent to a middle portion of the bridge 2206. Whenthe implant 2200 and inserter 2300 are each in the free state, thecentral junction 2430 may contact the bridge 2206, or the centraljunction 142 may optionally be separated from the bridge by a gap 2431.The proximal portions 2424, 2428 extend away from the bridge 2206generally opposite the bone engaging members 2202, 2204. The implant2200 may be pre-loaded on the inserter 2300 in a package, such as asterile package, with the implant 2200 in the free state.

With the control member 2700 in the second control position, the implant2200 may be decoupled or disconnected from the inserter 2300 byactuating the inserter 2300, disengaging the dovetail grooves 2526, 2626from the connecting means 2214, 2215, 2216, 2217 by sliding the dovetailgrooves 2526, 2626 outwardly left and right. The connection between theinserter 2300 and the implant 2200 may be ruptured by changing the shapeof the inserter 2300.

Referring to FIGS. 5A-5B, when the implant 2200 is coupled to theinserter 2300, the walls 2522, 2524, 2622, 2624 may not extend below thelower surface 2210 of the bridge 2206, due at least in part to thearrangement of the surfaces 2218, 2219, 2220, 2221 of the connectingmeans 2214, 2215, 2216, 2217 being proximally offset from the lowersurface 2210 of the bridge 2206. Instead, the walls 2522, 2524, 2622,2624 may be even with, or flush with, the lower surface 2210; orproximally spaced apart from, or proximally offset from, the lowersurface 2210. More specifically, the distal-most aspect of each wall2522, 2524, 2622, 2624 may be at the same level as, or proximal to, thelower surface 2210. This is significant because the lower surface 2210may contact a bone surface when the implant 2200 is implanted. Inexamples where the walls 2522, 2524, 2622, 2624 are flush with, orproximally offset from, the lower surface 2210, the implant 2200 may befully seated against the bone surface without interference from thewalls 2522, 2524, 2622, 2624 against the bone surface. Referring to FIG.9C, the dashed extension lines 2210′, 2210″ show the level of the lowersurface 2210 when the implant 2200 is in the free state. FIG. 5Billustrates that the bridge 2206, connecting means 2214, 2215, 2216,2217, and the entire inserter 2300 are located on the proximal side ofthe lower surface 2210.

Referring to FIGS. 5A-5B, when the implant 2200 is coupled to theinserter 2300, the inserter 2300 may be actuated to urge the implant2200 into an elastically deformed state. The inserter 2300 may be movedfrom the free state to the compressed state, or to a first, second, orhigher locked state if the first and second clip features 2434, 2436 arepresent. With the control member 2700 in the first control position, asthe inserter 2300 moves from the free state to the compressed state orthe locked state, the capture members 2500, 2600 rotate proximallyrelative to the central junction 2430 and the gap 2431 decreases untilthe central junction 2430 contacts the upper surface 2208 of the bridge2206 and presses the bridge distally against the resistance of thedovetail grooves 2526, 2626 engaged with the connecting means 2214,2215, 2216, 2217. The control member 2700 may press distally against thecentral junction 2430 as the inserter 2300 is actuated. In the example,the central junction 2430 contacts and pushes against the middle of theupper surface 2208 to put the bridge into three point bending. However,the central junction 2430 may be designed to contact and push against adifferent location along the upper surface 2208, or multiple locations.A central junction designed to contact two separate locations along theupper surface 2208 would put the bridge into four point bending, forexample. While in the illustrated example, the proximal portions 2424,2428 are moved toward each other to actuate the inserter 2300, in otherexamples the proximal portions 2424, 2428 may be moved away from eachother, or otherwise moved relative to each other, to actuate theinserter 2300.

Actuating the inserter 2300 from the free state to the compressed stateor the locked state puts the implant 2200 into an elastically deformedstate in which the distal ends 2236, 2240 of the bone engaging members2202, 2204 are farther away from each other than they are in the implantfree state. The inserter 2300 may urge the implant 2200 into a firstelastically deformed state in which the distal ends 2236, 2240 arefarther apart than they are in the implant free state, but not as farapart as the proximal ends 2234, 2238, so that the bone engaging members2202, 2204 still converge slightly; a second elastically deformed statein which the distal ends 2236, 2240 and the proximal ends 2234, 2238 arethe same distance apart, so that the bone engaging members 2202, 2204are parallel, at least to the unaided eye; or a third elasticallydeformed state in which the distal ends 2236, 2240 are farther apartthan are the proximal ends 2234, 2238, so that the bone engaging members2202, 2204 diverge.

As the inserter 2300 moves from the compressed state or the locked stateto the free state, the capture members 2500, 2600 rotate distallyrelative to the central junction 2430 and the central junction 2430moves away from the upper surface 2208 of the bridge 2206 to allow thebridge 2206 and the entire implant 2200 to relax toward the implant freestate.

In this example, the implant 2200 may be decoupled or disconnected fromthe inserter 2300 when the implant 2200 is in the free state or anelastically deformed state. The inserter 2300 may be decoupled ordisconnected from the implant 2200 when the inserter 2300 has beenprepared for implant disconnection by moving the control member 2700 tothe second control position.

A surgical method for stabilizing first and second bone fragments mayinclude any or all of the following steps in any order: preparing afirst hole in the first bone fragment; inserting a temporary fixationpin in the first hole; preparing a second hole in the second bonefragment; determining an implant size corresponding to the first andsecond holes; selecting the proper size implant 2200; coupling theselected implant 2200 to the inserter 2300, the implant 2200 in the freestate; urging the implant 2200 into an elastically deformed state;inserting the bone engaging member 2202 into the first hole and the boneengaging member 2204 into the second hole; seating the lower surface2210 against a surface of the first or second bone fragment; allowingthe implant 2200 to relax toward the implant free state; and decouplingthe inserter 2300 from the implant 2200. Allowing the implant 2200 torelax toward the implant free state may comprise releasing inwardpressure on the proximal portions 2424, 2428. Optionally, allowing theimplant 2200 to relax toward the implant free state may comprisedisengaging the first and second clip features 2434, 2436.

Any methods disclosed herein includes one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure or characteristicdescribed in connection with that embodiment is included in at least oneembodiment. Thus, the quoted phrases, or variations thereof, as recitedthroughout this specification are not necessarily all referring to thesame embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, Figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim require morefeatures than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.Thus, the claims following this Detailed Description are herebyexpressly incorporated into this Detailed Description, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements recited inmeans-plus-function format are intended to be construed in accordancewith 35 U.S.C. § 112 Para. 6. It will be apparent to those having skillin the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the technology.

While specific embodiments and applications of the present technologyhave been illustrated and described, it is to be understood that thetechnology is not limited to the precise configuration and componentsdisclosed herein. Various modifications, changes, and variations whichwill be apparent to those skilled in the art may be made in thearrangement, operation, and details of the methods and systems of thepresent technology disclosed herein without departing from the spiritand scope of the technology.

1. A system comprising: an implant comprising a body, a left retainer,and a right retainer, wherein the body extends between a left end and aright end to establish a longitudinal direction of the body, wherein theleft retainer protrudes from the left end of the body, wherein the rightretainer protrudes from the right end of the body; and an inserterreleasably connectable to the implant, the inserter comprising a leftconnection, a right connection, and an intermediate connection betweenthe left and right connections; wherein when the inserter is connectedto the implant, the left connection engages the left retainer, the rightconnection engages the right retainer, and the intermediate connectionis adjacent to the body; wherein when the inserter is connected to theimplant, the system is movable between a free state and an actuatedstate, wherein in the free state the body is undeformed by the inserter,wherein in the actuated state the body is elastically deformed bypressure from the intermediate connection acting against resistance fromthe left and right connections.
 2. The system of claim 1, wherein theleft and right retainers extend along the longitudinal direction of thebody.
 3. The system of claim 1, wherein the body extends between a frontside and an opposite back side to establish a front to back direction ofthe body, wherein the left and right retainers extend along the front toback direction.
 4. The system of claim 1, wherein the body extendsbetween a body lower surface and an opposite body upper surface, whereinthe left retainer extends between a left lower surface and an oppositeleft upper surface, wherein the right retainer extends between a rightlower surface and an opposite right upper surface, wherein the bodyupper surface and the left and right lower surfaces are on the same sideof the body lower surface.
 5. The system of claim 4, wherein when theinserter is connected to the implant, the body upper surface and theentire inserter are on the same side of the body lower surface.
 6. Thesystem of claim 5, wherein the body lower surface is a bone facingsurface.
 7. The system of claim 1, wherein the left connection is a leftjaw, wherein the right connection is a right jaw, wherein theintermediate connection is a junction; wherein when the inserter isconnected to the implant, the left jaw engages under the left retainer,the right jaw engages under the right retainer, and the junction isadjacent to the body.
 8. A system comprising: an implant comprising abody, a left retainer, and a right retainer, wherein the body comprisesa bone contacting surface, wherein the body extends between a left endand a right end to establish a longitudinal direction of the body,wherein the left retainer protrudes from the left end of the body,wherein the right retainer protrudes from the right end of the body; andan inserter releasably connectable to the implant, the insertercomprising a left connection, a right connection, and an intermediateconnection between the left and right connections; wherein when theinserter is connected to the implant, the left connection engages theleft retainer, the right connection engages the right retainer, and theintermediate connection is adjacent to the body, wherein the left andright retainers and the entire inserter are all on the same side of thebone contacting surface; wherein when the inserter is connected to theimplant, the system is movable between a free state and an actuatedstate, wherein in the free state the body is undeformed by the inserter,wherein in the actuated state the body is elastically deformed bypressure from the intermediate connection acting against resistance fromthe left and right connections.
 9. The system of claim 8, wherein theleft and right retainers extend along the longitudinal direction of thebody.
 10. The system of claim 8, wherein the body extends between afront side and an opposite back side to establish a front to backdirection of the body, wherein the left and right retainers extend alongthe front to back direction.
 11. The system of claim 8, wherein the bodycomprises an upper surface opposite the bone contacting surface, whereinthe left retainer extends between a left lower surface and an oppositeleft upper surface, wherein the right retainer extends between a rightlower surface and an opposite right upper surface, wherein the uppersurface of the body and the left and right lower surfaces are on thesame side of the bone contacting surface.
 12. The system of claim 8,wherein the left connection is a left hook, wherein the right connectionis a right hook, wherein the intermediate connection is a junction;wherein when the inserter is connected to the implant, the left hookengages under the left retainer, the right hook engages under the rightretainer, and the junction is adjacent to the body.
 13. A systemcomprising: a bone staple comprising a bridge, a left leg, a right leg,a left retainer, and a right retainer, wherein the bridge extendsbetween a left end and a right end to establish a longitudinal directionof the bridge, wherein the left leg comprises a left proximal end thatis attached to the left end of the bridge, wherein the left legterminates in a left distal end opposite the bridge, wherein the rightleg comprises a right proximal end that is attached to the right end ofthe bridge, wherein the right leg terminates in a right distal endopposite the bridge, wherein the right leg extends beside the left leg,wherein the left and right proximal ends are separated by a firstdistance, wherein the left retainer is attached to and extends from theleft end of the bridge, wherein the right retainer is attached to andextends from the right end of the bridge, wherein the bone staple ismovable between a staple free state and an elastically deformed state,wherein when the bone staple is in the staple free state, the staple isundeformed and the left and right distal ends are separated by a seconddistance which is less than the first distance, wherein when the bonestaple is in the elastically deformed state, the left and right distalends are separated by a third distance which is greater than the seconddistance; and an inserter releasably connectable to the bone staple, theinserter comprising a left connector, a right connector, and anintermediate connector, wherein the left connector faces the rightconnector, wherein the intermediate connector is between the left andright connectors, wherein the inserter is movable between an inserterfree state and an actuated state; wherein when the inserter in theinserter free state is connected to the bone staple in the staple freestate, the left connector engages the left retainer, the right connectorengages the right retainer, and the intermediate connector is adjacentto the bridge, between the left and right ends of the bridge, andopposite the left and right legs; wherein when the inserter in theactuated state is connected to the bone staple in the elasticallydeformed state, the left connector engages the left retainer, the rightconnector engages the right retainer, and the intermediate connectorpresses against the bridge between the left and right ends of the bridgeand opposite the left and right legs.
 14. The system of claim 13,wherein the left and right retainers extend along the longitudinaldirection.
 15. The system of claim 13, wherein the bridge extendsbetween a front side and an opposite back side to establish a front toback direction of the bridge, wherein the left and right retainersextend along the front to back direction.
 16. The system of claim 13,wherein the bridge extends between a bridge lower surface and anopposite bridge upper surface, wherein the left retainer extends betweena left lower surface and an opposite left upper surface, wherein theright retainer extends between a right lower surface and an oppositeright upper surface, wherein the bridge upper surface and the left andright lower surfaces are on the same side of the bridge lower surface.17. The system of claim 16, wherein when the inserter is connected tothe bone staple, the bridge upper surface and the entire inserter are onthe same side of the bridge lower surface.
 18. The system of claim 17,wherein the bridge lower surface is a bone contacting surface.
 19. Thesystem of claim 13, wherein the third distance is equal to the firstdistance.
 20. The system of claim 13, wherein the third distance isgreater than the first distance.